(261 days)
The SilentCloud in combination with a Tinnitus Management Program is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use.
The target population for the Universal Tinnitus Management System are adult tinnitus patients over 18 years. The SilentCloud is intended to provide relief from the disturbance of chronic subjective timitus while using the device.
The SlientCloud is fitted and programmed by a qualified healthcare professional familiar with timitus treatment.
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This looks like a 510(k) clearance letter for a medical device called SilentCloud, a therapeutic software tool for the treatment of chronic subjective tinnitus.
However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. The letter is a formal notification from the FDA stating that the device has received substantial equivalence and can be marketed, but it doesn't detail the technical performance studies that led to this clearance.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) summary, clinical study reports, or other documentation detailing the device's technical and clinical performance validation.
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.